
ABOUT ALTASCIENCES
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
FEATURED CONTENT
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What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.
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Combining certain Phase 2 studies with the Phase 1 protocol gives you earlier access to data, enabling more informed go/no-go decisions early in the program. This strategy makes it possible to accelerate drug development and better allocate resources.
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By completing your trials in Canada, you can accelerate your early phase clinical research by six to nine weeks compared to an IND submission in the U.S.
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Discover how ethnobridging streamlines the approval process in Asian markets and addresses potential disparities in drug metabolism between Asian and non-Asian populations.
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A recent FDA draft guidance aims to address health disparities and enhance data quality with action plans for greater inclusivity in clinical trials. Explore practical steps to building trust and inclusivity in clinical research.
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Choosing the right CRO/CDMO for your first-in-human (FIH) trials enables you to run a successful study that generates high-quality data with speed and ease.
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For CNS drugs that need assessment of their impact on driving ability, Altasciences offers faster study start-up and lower costs with on-site driving simulators.
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This FAQ list offers clarity on pivotal aspects of your drug development journey, ensuring studies in Canada pave the way for U.S. FDA and EMA submissions.
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In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development.
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Discover how the complexity and challenges of bringing ophthalmic therapeutics to market can be mitigated by entrusting your drug development program to an integrated CRO/CDMO partner.
FEATURED WEBINARS
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Globally recognized consultants discuss how they are addressing the most pressing drug development topics in the ocular field.
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Gain valuable insights into the cutting-edge approaches shaping the future of gene and cell therapy delivery, ensuring more effective and efficient translation from discovery to clinical application.
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As GLP-1 drugs reshape the market, understanding their potential risks, applications, and economic effects is crucial for professionals in the pharmaceutical and healthcare industries.
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<p>Learn how CROs and CDMOs work in tandem to successfully address operational and regulatory challenges for pharmaceutical and biotech companies, and how this can determine study success or failure.</p>
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The video dives into the obstacles of the traditional outsourcing relationship between CROs and sponsors, and how Altasciences has broken from tradition to offer an alternative model.
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A comprehensive review of optimal timing and methodologies for cognitive and pharmacodynamic testing during first-in-human trials on CNS-active compounds.
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Learn about a unique, integrated program management strategy that can lower your costs and reduce program timelines from lead candidate selection to clinical proof-of-concept by up to 40%.
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Join our panel of experts for an in-depth review of the FDA's guidance on psychedelic drug development, exploring necessary methodological adaptations for safety, pharmacology, and efficacy.
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Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.
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In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.
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Watch this video in which Altasciences’ regulatory experts share key insights on Health Canada’s Clinical Trial Application (CTA) regulatory submission process.
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Discover the crucial insights and methodological adaptations needed to effectively assess the safety, pharmacology, and efficacy of innovative psychedelic compounds designed for specific medical applications.
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Dr. Beatrice Setnik, Altasciences' Chief Scientific Officer, walks through the differences between early and late QT prolongation testing.
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Dr. Beatrice Setnik, Chief Scientific Officer at Altasciences, discusses tactics for a successful clinical development pathway for CNS-active drugs.
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Altasciences and Sygnature Discovery discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs.
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Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.
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This session explores the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy evaluation of a CNS-active drug in early clinical trials.
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Learn how ethnic differences can impact the bioavailability of your drug candidate and strategies for the design of your multiregional clinical development program.
CONTACT INFORMATION
Altasciences
1510 Delp Drive
Harleysville, PA 19438
UNITED STATES
Contact: contact@altasciences.com
FEATURED SOLUTIONS
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We specialize in DDI studies, including stand-alone and 'cocktail' designs, assessing multiple CYP enzymes or transporters in single studies, from simple crossovers to complex adaptive trials.
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Altasciences has successfully designed, conducted, analyzed, and reported numerous clinical trials focused on renal and hepatic impairment across a wide range of therapeutic areas.
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Altasciences has over 25 years of experience in metabolic diseases and supports every stage of the development process, from discovery to clinical trials — and beyond.
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Did you know? Altasciences’ clinical facilities are integrated with state-of-the-art flow cytometry laboratories. With our deep expertise in regulated cellular analysis, our team ensures that every step — from sample collection and processing to transport and analysis — is optimized for precision and speed.
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Our network of 150+ active clinical trial sites allows us to identify potential partners that align with your therapeutic area, geographic preference, and specialty population requirements.
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Need help with inclusion/exclusion criteria for your Phase 2/3 protocol or an unexpected FDA post-marketing amendment? Altasciences offers reliable solutions with a quick start-up.
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With over 60 HAP studies successfully conducted in the last decade, Altasciences has experience in diverse areas such as for stimulants, opioids, and sedative-hypnotics.
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Our approach is designed to optimize efficiency and accelerate timelines, resulting in up to 40% time savings throughout the early phases of your drug development journey.
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As a leading partner in ocular therapy, Altasciences is at the forefront of ophthalmic drug development. Our integrated CRO/CDMO solutions can support your program from lead candidate selection to market. You will benefit from working with a single partner as your product advances through each phase of drug development—from prototype formulation through preclinical testing, to early phase clinical trials, and manufacturing. This could mean up to 40% in time savings.
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Altasciences recruits from a large ethnic population in Southern California and have a dedicated Asian recruitment and outreach department to liaise with our participants.
FEATURED AUDIO
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Drug development in the ocular space has specific challenges. Explore how an end-to-end solution can facilitate a path to Phase 2.
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Discover how having early access to trial results and data can help to make inform decisions later in the development journey, support funding opportunities, and help solidify plans around sound data.
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Discover how local ethnobridging studies during Phase I can reduce drug development timelines by the number of years typically needed to complete clinical development in a target region.
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Dr. Beatrice Setnik, Chief Scientific Officer at Altasciences, discusses the drug and vaccine development process to provide insight on the typical timelines for getting a vaccine to market.
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Learn about best practices and approaches in Phase I clinical trials, from conceptualization and initial protocol development, collection and analysis, through final regulatory submission.
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Schedule I, or Class I (CI) drugs are currently restricted to research in the U.S. Explore the challenges associated with Schedule I therapeutic development.
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A first-in-human clinical trial is a significant milestone in the development of a potential new drug. Listen and learn how to plan your first in-human clinical trial.
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In this issue, review complex considerations for the development of central nervous system-active drugs, including the Controlled Substances Act, preclinical and clinical data requirements, and additional assessments your program may need.
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First-in-human (FIH) trials in the early phases of drug development represent a critical milestone in the approval of medicines.
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Listen to this discussion on global regulations, design, and timing of QT assessment, including a case study from a first-in-human clinical trial.
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Discuss effective pharmaceutical therapies, specifically, understanding the intrinsic and extrinsic factors that alter exposure to limit adverse effects and maximize treatment response.
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Learn why hybrid medicines require re-approval for market authorization, partly based on data from the original reference medicine, and partly on data from new clinical trials on the modified version.